JP3146616B2 - Dried formulation dissolved kit - Google Patents

Dried formulation dissolved kit

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Publication number
JP3146616B2
JP3146616B2 JP10921892A JP10921892A JP3146616B2 JP 3146616 B2 JP3146616 B2 JP 3146616B2 JP 10921892 A JP10921892 A JP 10921892A JP 10921892 A JP10921892 A JP 10921892A JP 3146616 B2 JP3146616 B2 JP 3146616B2
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Japan
Prior art keywords
syringe
vial
portion
formed
kit
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Expired - Fee Related
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JP10921892A
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Japanese (ja)
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JPH05277156A (en
Inventor
隆英 岡本
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株式会社ニッショー
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Description

【発明の詳細な説明】 DETAILED DESCRIPTION OF THE INVENTION

【0001】 [0001]

【産業上の利用分野】本発明は乾燥製剤溶解キットに関する。 The present invention relates to a dry formulation dissolved kit. さらに詳しくは、病院等で粉末製剤や固形製剤、 More specifically, powder formulations or solid formulations in a hospital or the like,
凍結乾燥製剤等の乾燥製剤を無菌的に調製しうる乾燥製剤溶解キットに関する。 The dried formulation such as freeze-dried preparation on Drying formulation dissolved kit capable of aseptically prepared.

【0002】 [0002]

【従来の技術】従来より乾燥製剤の溶解はつぎのようにして行われている。 Dissolution of a conventional than dry formulations are carried out as follows.

【0003】まず、溶解液の入っているアンプルと乾燥製剤の入っている小形バイアルを机上に並べ、シリンジでアンプルから溶解液を吸引して取り出し、つぎにバイアルに前記溶解液を注入して移し替え、バイアル中で乾燥製剤を溶解液中に溶解する。 [0003] First, arrange a small vial containing the ampules and dried formulation that contains the solution on a desk, off with suction lysates from ampoule syringes, and then transferred by injecting the solution into a vial instead, it dissolved in solution in the dry formulation in a vial. その後、バイアル中の薬液を再びシリンジで吸引し、人体への注射等に用いる。 Thereafter, the chemical in the vial was again aspirated with syringes used for injection or the like to the human body.

【0004】 [0004]

【発明が解決しようとする課題】ところが前記従来方法であると、シリンジによる吸引注入操作を繰り返えさなければならないので、操作が繁雑であり、しかもアンプルを開口した状態で作業するので無菌的操作ができないという問題がある。 If it is however the conventional method [0005], since it must be Kaee repeated aspiration injection operation by syringe, the operation is complicated, yet aseptic operation since the work in a state of opening the ampoule there is a problem that can not be. 本発明は、かかる事情に鑑み、溶解操作が簡単迅速であり、かつ無菌的に行いうる乾燥製剤溶解キットを提供することを目的とする。 In view of such circumstances, dissolution operation is simple rapid and aims to provide a dry formulation dissolution kit may aseptically performed.

【0005】 [0005]

【課題を解決するための手段】本発明の乾燥製剤溶解キットは、乾燥製剤が収容されている薬剤バイアルと、溶解液が充填されると共にチップ先端が薄膜で閉塞されているプレフィルドシリンジと、前記両者を連結して保持すると共に連通操作をガイドする連通器具とからなり、 Means for Solving the Problems] Dry formulations dissolved kit of the present invention includes a drug vial dry formulation is accommodated, a prefilled syringe tip tip is closed by a thin film with lysate is filled, the It consists of a communication device for guiding the communication operation and holds by connecting the two,
該連通器具は、内周面が円筒状で、軸方向の途中に隔壁が形成されており、一端側が前記薬剤バイアルの口部を軸方向に摺動自在に保持するバイアル保持部に形成され、他端側が前記シリンジの筒部を軸方向に摺動自在に保持するシリンジ保持部に形成され、前記隔壁に両端に穿刺部を有する移注針が固定されていることを特徴とする。 The communicating instrument, the inner peripheral surface a cylindrical, are partition walls in the middle of the axial direction is formed and is formed in a vial holder which is one end slidably holding the mouth of the drug vial in the axial direction, the other end side is formed in the syringe holding portion for slidably holding the cylindrical portion of the syringe axially moved injection needle having a puncture at both ends to said partition wall, characterized in that it is fixed.

【0006】 [0006]

【作用】本発明の溶解キットでは、保管輸送時は連通器具のバイアル保持部に薬剤バイアルの口部を挿入し、シリンジ保持部にプレフィルドシリンジの筒部を挿入しておかれる。 [Action] lysis kit of the present invention, during storage transport inserts the mouth of the drug vial to the vial holder of the communication device is placed by inserting the cylindrical portion of the pre-filled syringe in the syringe holding section. そして、使用時には、バイアルとプレフィルドシリンジを連通器具内に押し込むと移注針の一端にバイアルの口部が刺通され、他端にプレフィルドシリンジのチップ先端の薄膜が刺通されて、両者が連通する。 At the time of use, the mouth of the vial at one end of the transfer needle is pushed vials and pre-filled syringe in communicating the instrument is pierced by a thin film of the tip end of the pre-filled syringe is pierced at the other end, both communicating to. この状態でプレフィルドシリンジのプランジャーを押し込めばシリンジ内の溶解液がバイアル内に移注され、バイアル内の乾燥製剤は溶解され薬液が調される。 If pushed the plunger of the pre-filled syringe in this state solution in the syringe is dispensed moved into the vial, dried formulation in the vial is made of chemical is dissolved tone. ついで、プレフィルドシリンジのプランジャーを後退させるとバイアル内の薬液がシリンジ内に注入されるので、プレフィルドシリンジを連通器具から引き抜いて注射針を刺せば直ちに人体への注射に使用しうる。 Then, since when retracting the plunger of the prefilled syringe chemical liquid in the vial is injected into the syringe can be used immediately injected to the human body if allowed an injection needle withdrawn prefilled syringe from the communication device. 以上のごとく本発明によれば、乾燥製剤の溶解を一連の簡単な操作で行え、しかも連通器具で密閉された空間内で無菌的に行うことができる。 According to the above as the present invention, the dissolution of the dry formulations can in a series of simple operations, yet can be performed aseptically in a sealed with communication instrument space.

【0007】 [0007]

【実施例】つぎに、本発明の実施例を説明する。 EXAMPLES Next, an example of the present invention. 図1において、1はプレフィルドシリンジ、2はバイアル、3 In Figure 1, 1 is pre-filled syringe, 2 vials, 3
は連通器具である。 It is a communication instrument. 前記プレフィルドシリンジ1(以下、シリンジ1という)は予め溶解液A(生理食塩水など)が注入されたシリンジであり、筒部11と先端のチップ部12とガスケット13を備えたプランジャ14とから構成されている。 The prefilled syringe 1 (hereinafter, referred to as the syringe 1) is a syringe pre-dissolved solution A (such as saline) was injected, composed from the plunger 14 that includes a cylindrical portion 11 and the distal end of the tip portion 12 and the gasket 13 It is. また、チップ部12の内部は薄膜15で閉塞されている。 Further, the inside of the tip portion 12 is closed by a membrane 15. バイアル2は公知の薬剤ビンで口部21はゴム栓22で密閉されており、内部には凍結乾燥製剤Bが収容されている。 Vial 2 is the mouth portion 21 in a known drug bottle is sealed with a rubber stopper 22 is accommodated lyophilized formulation B inside.

【0008】連通器具3は円筒状の部材であり、軸方向の途中に隔壁31が形成されており、該隔壁31には両端に穿刺部4a、4bを有する移注針4が固定されている。 [0008] communication device 3 is a cylindrical member, which is the partition wall 31 in the middle in the axial direction is formed, the puncture portion 4a at both ends in the partition wall 31, the transfer needle 4 having 4b are fixed . そして、連通器具3の一端側はシリンジ保持部32であり、前記シリンジ1の筒部11を摺密に保持するようになっている。 Then, one end of the communication device 3 is the syringe holding portion 32, so as to hold the cylindrical portion 11 of the syringe 1 in Surimitsu. すなわち、シリンジ1の筒部11は外力を加えない状態では簡単に抜け出ることはなく、しかし人力で押し込めば簡単な操作力で内部に押し込みうるように保持されている。 That is, the cylindrical portion 11 of the syringe 1 is held as can push the inside by a simple operation force is not being withdrawn easily in the state without the addition of external force, but if pushed by human power. また、連通器具3の他端側はバイアル保持部33 The other end of the communication device 3 is the vial holder 33
であり、前記バイアル2の口部21を摺密に保持するようになっている。 , And the adapted to hold the mouth 21 of the vial 2 to Surimitsu. すなわち、バイアル2の口部21は外力を加えない状態では簡単に抜け出ることなく、しかし人力で押し込めば軽い操作力で内部に押し込みうるように保持されている。 That, is held so as mouth portion 21 of the vial 2 without being withdrawn easily in the state without the addition of external force, but may push the inside with a light operating force when pushed by human power. なお、34,35 はOリングである。 In addition, 34 and 35 is an O-ring. 上記の溶解キットは、通常は図1に示すように連通器具3の一端側にバイアル2を、他の端側にシリンジを挿入し、互いに連通器具3で連結した状態で保持され、保管される。 The above dissolution kit, usually a vial 2 at one end of the communicating device 3 as shown in FIG. 1, insert the syringe into the other end side is held in a state of being connected in communicating apparatus 3 to each other, it is stored .

【0009】つぎに、上記溶解キットの使用方法を説明する。 [0009] Next, a method used for the dissolution kit. まず図2(I)に示すように、連通器具3のシリンジ保持部32内にシリンジ1の筒部11を押し込み、さらにバイアル保持部33内にバイアル2の口部21を押し込む。 First, as shown in FIG. 2 (I), pushing the tubular portion 11 of the syringe 1 into the syringe holding portion 32 of the communication device 3, pushing the mouth portion 21 of the vial 2 further vial holder 33. これによりシリンジ1のチップ部12の薄膜15が移注針4の穿刺部4aで穿刺され、さらにバイアル2の口部21 Thereby a thin film 15 of the tip 12 of the syringe 1 is punctured with the puncturing section 4a of the transfer needle 4, further vial 2 of the mouth portion 21
のゴム栓22が移注針4の穿刺部4bで穿刺されシリンジ1 The rubber stopper 22 is punctured with puncturing portion 4b of the transfer needle 4 syringe 1
とバイアル2が移注針4を介して連通する。 And the vial 2 are communicated with each other through the transfer needle 4. つぎに図2 Next, FIG. 2
(II)に示すように、シリンジ1のプランジャ14をいったん押し込むと、シリンジ1内の溶解液Aが実線矢印で示すように、移注針4を通ってバイアル2内に注入され、これによりバイアル2内の乾燥製剤Bが溶解され、 As shown in (II), once pushed the plunger 14 of the syringe 1, solution A in the syringe 1 as indicated by solid arrows, it is injected into the vial 2 through the Utsurichuhari 4, thereby vial dry formulation B in 2 are dissolved,
液体の薬液が作られる。 Chemical liquid is made. この後、前記プランジャ14を元の位置に引き戻すと点線矢印で示すように薬液Cがシリンジ1内に移注される。 Thereafter, the chemical C as shown when pulling back the plunger 14 to its original position by the dotted line arrow is dispensed transferred to the syringe 1. このようにして、溶解された薬液をシリンジ1に注入し終えたら、図3に示すように連通器具3からシリンジ1を引き抜き、ついでチップ部12 In this way, when the dissolved chemical finished injected into the syringe 1, pull the syringe 1 from the communication device 3 as shown in FIG. 3, and then the tip portion 12
に注射用の針を差し込むと、人体への注射に直ちに使用することができる。 When inserting the needle for injection, it can be immediately used for injection into the human body.

【0010】以上のごとく本実施例では、連通器具3への差し込み、引き抜きという一連の操作だけで乾燥製剤の溶解とシリンジへの移注を行いうるので、操作が簡便であり、しかも溶解液Aや薬液Cの移注が連通器具3で囲まれた密閉空間内で行われるので無菌操作が可能である。 [0010] In the above as the embodiment, the insertion of the communication device 3, as it can perform transfuse to dissolution and syringe just dry formulation series of operations of withdrawal, the operation is simple, yet solution A since transfusing of or chemical C is carried out in a closed space surrounded by the communicating device 3 is capable aseptic technique.

【0011】 [0011]

【発明の効果】本発明によれば連通器具への差し込み、 Merge to communication device according to the present invention,
引き抜きという一連の操作だけで乾燥製剤の溶解とシリンジへの移注を行いうるので、操作が簡便であり、しかも溶解液や薬液が連通器具で囲まれた密閉空間内で行われるので無菌操作が可能である。 Since only a series of operations in the can do transfuse dissolution and to the syringe of the dry formulation of withdrawal, the operation is simple, yet solution or chemical solution aseptic because performed in closed space surrounded by the communicating instrument possible it is.

【図面の簡単な説明】 BRIEF DESCRIPTION OF THE DRAWINGS

【図1】本発明の一実施例にかかわる乾燥製剤溶解キットの要部断面図である。 1 is a fragmentary cross-sectional view of a dry formulation dissolution kit according to an embodiment of the present invention.

【図2】(I)はシリンジ1とバイアル2の連通操作の説明図、(II)は溶解操作の説明図である。 [2] (I) is an explanatory view of a communication operation of the syringe 1 and the vial 2 is an explanatory view of (II) is dissolved operation.

【図3】連通器具3からシリンジ1を抜き取る操作の説明図である。 3 is an explanatory view of the operation to withdraw from the communication device 3 a syringe 1.

【符号の説明】 DESCRIPTION OF SYMBOLS

1 プレフィルドシリンジ 2 バイアル 1 prefilled syringe 2 vials
3 連通器具 4 移注針 11 筒部 Third communication device 4 Utsurichuhari 11 cylindrical portion
12 チップ部 15 薄膜 21 口部 12 tip portion 15 thin film 21 neck portion
22 ゴム栓 31 隔壁 32 シリンジ保持部 22 rubber plug 31 septum 32 syringe holder
33 バイアル保持部 33 vials holding unit

Claims (1)

    (57)【特許請求の範囲】 (57) [the claims]
  1. 【請求項1】乾燥製剤が収容されている薬剤バイアルと、溶解液が充填されると共にチップ先端が薄膜で閉塞されているプレフィルドシリンジと、前記両者を連結して保持すると共に連通操作をガイドする連通器具とからなり、該連通器具は、内周面が円筒状で、軸方向の途中に隔壁が形成されており、一端側が前記薬剤バイアルの口部を軸方向に摺動自在に保持するバイアル保持部に形成され、他端側が前記シリンジの筒部を軸方向に摺動自在に保持するシリンジ保持部に形成され、前記隔壁に両端に穿刺部を有する移注針が固定されていることを特徴とする乾燥製剤溶解キット。 And 1. A medication vial dry formulation is accommodated, lysates guide the prefilled syringe tip tip is closed by a thin film while being filled, the communication operation and holds by connecting the two consists of a communication device, the communicating instrument, the inner peripheral surface a cylindrical, are partition walls in the middle of the axial direction is formed, and one end side slidably holding the mouth of the drug vial in the axial direction vial It is formed in the holding portion, that the other end side is formed in the syringe holding portion for slidably holding the cylindrical portion of the syringe axially moved injection needle having a puncture at both ends to said partition wall is fixed dry formulations dissolved kit characterized.
JP10921892A 1992-04-01 1992-04-01 Dried formulation dissolved kit Expired - Fee Related JP3146616B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP10921892A JP3146616B2 (en) 1992-04-01 1992-04-01 Dried formulation dissolved kit

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP10921892A JP3146616B2 (en) 1992-04-01 1992-04-01 Dried formulation dissolved kit

Publications (2)

Publication Number Publication Date
JPH05277156A JPH05277156A (en) 1993-10-26
JP3146616B2 true JP3146616B2 (en) 2001-03-19

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Application Number Title Priority Date Filing Date
JP10921892A Expired - Fee Related JP3146616B2 (en) 1992-04-01 1992-04-01 Dried formulation dissolved kit

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Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB9611562D0 (en) * 1996-06-03 1996-08-07 Applied Research Systems Device
US6113583A (en) * 1998-09-15 2000-09-05 Baxter International Inc. Vial connecting device for a sliding reconstitution device for a diluent container
JP4341239B2 (en) 2002-12-19 2009-10-07 ニプロ株式会社 Liquid transfer Chugu
JP5199176B2 (en) * 2009-04-30 2013-05-15 株式会社吉野工業所 Two-part mixing vessel
DK2644180T3 (en) * 2011-04-12 2018-08-27 Hoffmann La Roche connection device
AU2013222819B2 (en) * 2012-01-27 2017-02-02 Michael A. Creaturo Safety syringe and safety dose combination kit
TW201643239A (en) * 2015-04-07 2016-12-16 Nissan Chemical Ind Ltd Method for manufacturing liquid medium composition, and manufacturing equipment and kit for the same

Also Published As

Publication number Publication date
JPH05277156A (en) 1993-10-26

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